# Immunology and Microbiology Devices; Revocation of the Exemption From Premarket Notification; Blood Culturing System Devices; Change of Compliance Date
> **Food and Drug Administration** · Final rule; change of compliance date for certain manufacturers and distributors. · Published 1995-10-27 · Effective 1995-10-25 · 60 FR 54942
## Document
- **Document number:** 95-26678
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 60 FR 54942
- **CFR reference:** 21 CFR 886
- **Publication date:** 1995-10-27
- **Effective date:** 1995-10-25
- **HHS docket:** Docket No. 91N-0063
## Abstract

The Food and Drug Administration (FDA) is changing the compliance date of the final rule published on July 27, 1995 (60 FR 38480), that revoked the exemption from the requirement of premarket notification for blood culturing system devices to allow a 60-day grace period for submission of premarket notifications and to change the April 22, 1996, deadline to a December 26, 1996, deadline for obtaining premarket clearance for manufacturers or initial distributors of the device that have already begun commercial distribution under the existing premarket notification exemption. This action is being taken in response to a request to reconsider the procedural requirements of the final rule.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/1995/10/27/95-26678/immunology-and-microbiology-devices-revocation-of-the-exemption-from-premarket-notification-blood)
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